Consumer and provider understanding of safety issues around online purchase of imported drugs -- Modification to Restore Respondents

Consumer and Provider Understanding of Safety Issues around Online Purchase of Imported Drugs

Interview Guide for Healthcare Providers

Thank you for taking the time to meet with us today. My name is _______ and this is ______, and we are with RTI International, a not-for-profit research organization headquartered in Research Triangle Park, North Carolina. We are working with the Food and Drug Administration (FDA) to learn from consumers and healthcare providers how they think about and make decisions about purchasing drugs on the Internet. This valuable input will help FDA in its efforts to communicate with consumers on issues related to buying prescription drugs on the Internet.

RTI considers issues of privacy and confidentiality to be very important. We will be asking you a series of questions and recording the information in order to correctly and completely capture your responses. The audiotape will not be used to create a verbatim transcript of our conversation. Rather, it will serve as a backup and provide clarification while the interview summary is being developed. Is it OK that we audiotape our interview?

[NOTE: Confirm with Interviewee on the recording that consent is granted and proceed appropriately. If consent is not given, take detailed handwritten notes.]

There are no right or wrong answers and it is okay to say, “I don’t know.” Your participation is completely voluntary. You may end the interview at any time. If we ask a question that you’d prefer not to answer, just tell us, and we’ll skip over it.

Do you have any questions for us before we begin?

[NOTE: Answer questions, if any.]

Interviewer Note: This interview may involve topics that are sensitive for the Interviewee. If the Interviewee seems to be uncomfortable with any question during the interview, remind him or her as needed of the following:

• Your participation in this research and the information you provide is confidential to the RTI research team. We will not share any information with FDA that could be used to identify you.

• In this kind of an interview, there are no right or wrong answers. All of your comments are important to us. We want to know your thoughts and perspectives on buying prescription drugs on the Internet.

• I can turn the tape off and take handwritten notes if that would make you more comfortable.

• For whatever reason, if you are uncomfortable with a question, you don’t have to answer it.

Question Guide

When you hear the phrase “buying prescription drugs on the Internet,” what comes to mind? This is not a test and there are no wrong answers, so just say anything that you associate with buying prescription drugs on the Internet. I will write down what you say.

Why do you think some patients choose the Internet instead of going to their local retail pharmacy? [Probe regarding availability, cost, time, convenience, recreational drug use, and elimination of direct contact with health care provider.]

Do you think there are any differences between prescription drugs bought on the Internet and prescription drugs bought at the local retail pharmacy? [If yes] What are some of the differences? [Probe regarding effectiveness, quality of medications, patient safety, continuity of care, elimination of direct contact with health care provider, quality of information, and ethics of virtual practice.]

Do you know who is responsible for making sure that the prescription drugs sold at local retail pharmacies are safe and effective?

How is important is it to you to know that the prescription drugs that a patient receives have been reviewed for safety and efficacy?

When you hear the term “Food and Drug Administration (FDA),” what comes to mind?

What role do you think government plays in making sure prescription drugs bought on the Internet are safe and effective?

What role should they play in making sure prescription drugs bought on the Internet are safe and effective?

Do you think that all prescription drugs sold at the local retail pharmacy are reviewed and approved by the FDA?

What about prescription drugs sold on the Internet? Are they reviewed and approved by the FDA?

What does it mean to you that a prescription drug has been “approved by the FDA”?

What does it mean to you if a prescription drug is “not approved by the FDA or unapproved”?

Would you be willing to buy prescription drugs not approved by the FDA? Why or why not?

Why do you think some people choose to buy prescription drugs not approved by the FDA? [Probe regarding availability, cost, and recreational drug use.]

Do you think prescription drugs sold by a well-known company in other countries are equivalent in safety and effectiveness to prescription drugs sold by the same company in the United States? Why or why not?

Would you say that prescription drugs can be safely purchased on the Internet? Why or why not? [If yes, ask:] What factors make you feel comfortable with the safety of these products sold on the Internet?

[If no, ask:] Under what circumstances, if any, could these products be made safe?

Have you ever recommended that a patient buy a prescription drug on the Internet? If so, why?

Have you ever discussed buying prescription drugs on the Internet with a patient?

[If yes, ask:] Did you convey any information on risks or differences between drugs purchased on the Internet and drugs purchased at the local pharmacy?

In your opinion, what differences are there between prescription drugs bought on the Internet and those purchased at the pharmacy?

What is your impression of the safety and effectiveness of prescription drugs sold on the Internet compared to those sold at the local pharmacy?

[If respondent has ever recommended that a patient buy a prescription drug on the Internet, ask:] Do you know who made the prescription drugs you recommended that your patients buy on the Internet?

[If respondent has NOT ever recommended that a patient buy a prescription drug on the Internet, ask:] Who do you think makes the prescription drugs sold on the Internet?

[Probe if needed:] Are they U.S.-based companies or companies based in other countries?

Have you ever recommended that patients buy drugs made outside the U.S.?

Are you concerned about who makes prescription drugs that are sold outside the U.S.? Why or why not?

Whose job do you think it is to educate the public about issues related to buying prescription drugs on the Internet that affect U.S. patients directly?

Closing

You’ve been very helpful and I appreciate the time you’ve taken to speak with me today. We are almost finished.

Is there anything else that came to mind while we were talking that you would like to add that was not reflected in the interview?

If you could offer one piece of advice to FDA regarding how they could communicate more useful information to consumers on issues related to buying prescription drugs on the Internet, what would that be?

Thank you, again, for the time you’ve taken to share your thoughts and ideas.

Turn off recording equipment.

[For Group 2 providers only say:] As I mentioned at the beginning of our conversation, we will send you an honorarium in appreciation for your time. May I have the address where you would like us to send the check?

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